Apparatus and method for manipulating or retracting tissue and anatomical structure

ABSTRACT

Integrated systems and associated method for manipulating tissues and anatomical or other structures in medical applications for the purpose of treating diseases or disorders or other purposes. In one aspect, the system includes a delivery device configured to deploy and implant anchoring devices for such purposes.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/762,657, entitled Apparatus and Method for Manipulating or RetractingTissue and Anatomical Structure, filed on Feb. 8, 2013, which is acontinuation of U.S. patent application Ser. No. 13/037,097, entitledApparatus and Method for Manipulating or Retracting Tissue andAnatomical Structure, filed on Feb. 28, 2011, which is a divisional ofU.S. patent application Ser. No. 11/492,690, now U.S. Pat. No.7,896,891, entitled Apparatus and Method for Manipulating or RetractingTissue and Anatomical Structure, filed on Jul. 24, 2006, which is acontinuation-in-part of U.S. patent application Ser. No. 11/318,246, nowU.S. Pat. No. 7,645,286, entitled Devices, Systems and Methods forRetracting, Lifting, Compressing, Supporting or Repositioning Tissues orAnatomical Structures, filed on Dec. 22, 2005, which is acontinuation-in-part of U.S. patent application Ser. No. 11/134,870, nowU.S. Pat. No. 7,758,594, entitled Devices, Systems and Methods forTreating Benign Prostatic Hyperplasia and Other Conditions, filed on May20, 2005, the entire disclosures of which are expressly incorporatedherein by reference.

FIELD OF THE INVENTION

The present invention relates generally to medical devices and methods,and more particularly to integrated systems and associated methods formanipulating or retracting tissues and anatomical or other structureswithin the body of human or animal subjects for the purpose of treatingdiseases or disorders and/or for cosmetic or reconstructive or otherpurposes.

BACKGROUND OF THE INVENTION

There are a wide variety of situations in which it is desirable to lift,compress or otherwise reposition normal or aberrant tissues oranatomical structures (e.g., organs, ligaments, tendons, muscles,tumors, cysts, fat pads, etc.) within the body of a human or animalsubject. Such procedures are often carried out for the purpose oftreating or palliating the effects of diseases or disorders (e.g.,hyperplasic conditions, hypertrophic conditions, neoplasias, prolapses,herniations, stenoses, constrictions, compressions, transpositions,congenital malformations, etc.) and/or for cosmetic purposes (e.g., facelifts, breast lifts, brow lifts, etc.) and/or for research anddevelopment purposes (e.g., to create animal models that mimic variouspathological conditions). In many of these procedures, surgicalincisions are made in the body and laborious surgical dissection isperformed to access and expose the affected tissues or anatomicalstructures. Thereafter, in some cases, the affected tissues oranatomical structures are removed or excised. In other cases, variousnatural or man made materials are used to lift, sling, reposition orcompress the affected tissues.

Benign Prostatic Hyperplasia (BPH)

One example of a condition where it is desirable to lift, compress orotherwise remove a pathologically enlarged tissue is Benign ProstaticHyperplasia (BPH). BPH is one of the most common medical conditions thataffect men, especially elderly men. It has been reported that, in theUnited States, more than half of all men have histopathologic evidenceof BPH by age 60 and, by age 85, approximately 9 out of 10 men sufferfrom the condition. Moreover, the incidence and prevalence of BPH areexpected to increase as the average age of the population in developedcountries increases.

The prostate gland enlarges throughout a man's life. In some men, theprostatic capsule around the prostate gland may prevent the prostategland from enlarging further. This causes the inner region of theprostate gland to squeeze the urethra. This pressure on the urethraincreases resistance to urine flow through the region of the urethraenclosed by the prostate. Thus the urinary bladder has to exert morepressure to force urine through the increased resistance of the urethra.Chronic over-exertion causes the muscular walls of the urinary bladderto remodel and become stiffer. This combination of increased urethralresistance to urine flow and stiffness and hypertrophy of urinarybladder walls leads to a variety of lower urinary tract symptoms (LUTS)that may severely reduce the patient's quality of life. These symptomsinclude weak or intermittent urine flow while urinating, straining whenurinating, hesitation before urine flow starts, feeling that the bladderhas not emptied completely even after urination, dribbling at the end ofurination or leakage afterward, increased frequency of urinationparticularly at night, urgent need to urinate etc.

In addition to patients with BPH, LUTS may also be present in patientswith prostate cancer, prostate infections, and chronic use of certainmedications (e.g. ephedrine, pseudoephedrine, phenylpropanolamine,antihistamines such as diphenhydramine, chlorpheniramine etc.) thatcause urinary retention especially in men with prostate enlargement.

Although BPH is rarely life threatening, it can lead to numerousclinical conditions including urinary retention, renal insufficiency,recurrent urinary tract infection, incontinence, hematuria, and bladderstones.

In developed countries, a large percentage of the patient populationundergoes treatment for BPH symptoms. It has been estimated that by theage of 80 years, approximately 25% of the male population of the UnitedStates will have undergone some form of BPH treatment. At present, theavailable treatment options for BPH include watchful waiting,medications (phytotherapy and prescription medications), surgery andminimally invasive procedures.

For patients who choose the watchful waiting option, no immediatetreatment is provided to the patient, but the patient undergoes regularexams to monitor progression of the disease. This is usually done onpatients that have minimal symptoms that are not especially bothersome.

Medications for treating BPH symptoms include phytotherapy andprescription medications. In phytotherapy, plant products such as SawPalmetto, African Pygeum, Serenoa Repens (sago palm) and South Africanstar grass are administered to the patient. Prescription medications areprescribed as first line therapy in patients with symptoms that areinterfering with their daily activities. Two main classes ofprescription medications are alpha-1a-adrenergic receptors blockers and5-alpha-reductase inhibitors. Alpha-1a-adrenergic receptors blockersblock that activity of alpha-1a-adrenergic receptors that areresponsible for causing constriction of smooth muscle cells in theprostate. Thus, blocking the activity of alpha-1a-adrenergic receptorscauses prostatic smooth muscle relaxation. This in turn reduces urethralresistance thereby reducing the severity of the symptoms.5-alpha-reductase inhibitors block the conversion of testosterone todihydrotestosterone. Dihydrotestosterone causes growth of epithelialcells in the prostate gland. Thus 5-alpha-reductase inhibitors causeregression of epithelial cells in the prostate gland and hence reducethe volume of the prostate gland which in turn reduces the severity ofthe symptoms.

Surgical procedures for treating BPH symptoms include TransurethalResection of Prostate (TURP), Transurethral Electrovaporization ofProstate (TVP), Transurethral Incision of the Prostate (TUIP), LaserProstatectomy and Open Prostatectomy.

Transurethal Resection of Prostate (TURP) is the most commonly practicedsurgical procedure implemented for the treatment of BPH. In thisprocedure, prostatic urethral obstruction is reduced by removing most ofthe prostatic urethra and a sizeable volume of the surrounding prostategland. This is carried out under general or spinal anesthesia. In thisprocedure, a urologist visualizes the urethra by inserting aresectoscope, that houses an optical lens in communication with a videocamera, into the urethra such that the distal region of the resectoscopeis in the region of the urethra surrounded by the prostate gland. Thedistal region of the resectoscope consists of an electric cutting loopthat can cut prostatic tissue when an electric current is applied to thedevice. An electric return pad is placed on the patient to close thecutting circuit. The electric cutting loop is used to scrape away tissuefrom the inside of the prostate gland. The tissue that is scraped awayis flushed out of the urinary system using an irrigation fluid. Using acoagulation energy setting, the loop is also used to cauterizetransected vessels during the operation.

Another example of a surgical procedure for treating BPH symptoms isTransurethral Electrovaporization of the Prostate (TVP). In thisprocedure, a part of prostatic tissue squeezing the urethra isdesiccated or vaporized. This is carried out under general or spinalanesthesia. In this procedure, a resectoscope is insertedtransurethrally such that the distal region of the resectoscope is inthe region of the urethra surrounded by the prostate gland. The distalregion of the resectoscope consists of a rollerball or a grooved rollerelectrode. A controlled amount of electric current is passed through theelectrode. The surrounding tissue is rapidly heated up and vaporized tocreate a vaporized space. Thus the region of urethra that is blocked bythe surrounding prostate gland is opened up.

Another example of a surgical procedure for treating BPH symptoms isTransurethral Incision of the Prostate (TUIP). In this procedure, theresistance to urine flow is reduced by making one or more incisions inthe prostate gland in the region where the urethra meets the urinarybladder. This procedure is performed under general or spinal anesthesia.In this procedure, one or more incisions are made in the muscle of thebladder neck, which is the region where the urethra meets the urinarybladder. The incisions are in most cases are deep enough to cut thesurrounding prostate gland tissue including the prostatic capsule. Thisreleases any compression on the bladder neck and causes the bladder neckto spring apart. The incisions can be made using a resectoscope, laserbeam etc.

Another example of a surgical procedure for treating BPH symptoms isLaser Prostatectomy. Two common techniques used for Laser Prostatectomyare Visual Laser Ablation of the Prostate (VLAP) and the Holmium LaserResection/Enucleation of the Prostate (HoLEP). In VLAP, aneodymium:yttrium-aluminum-garnet (Nd:YAG) laser is used to ablatetissue by causing coagulation necrosis. The procedure is performed undervisual guidance. In HoLEP, a holmium:Yttrium-aluminum-garnet laser isused for direct contact ablation of tissue. Both these techniques areused to remove tissue obstructing the urethral passage to reduce theseverity of BPH symptoms.

Another example of a surgical procedure for treating BPH symptoms isPhotoselective Vaporization of the Prostate (PVP). In this procedure,laser energy is used to vaporize prostatic tissue to relieve obstructionto urine flow in the urethra. The type of laser used is thePotassium-Titanyl-Phosphate (KTP) laser. The wavelength of this laser ishighly absorbed by oxyhemoglobin. This laser vaporizes cellular waterand hence is used to remove tissue that is obstructing the urethra.

Another example of a surgical procedure for treating BPH symptoms isOpen Prostatectomy. In this procedure, the prostate gland is surgicallyremoved by an open surgery. This is done under general anesthesia. Theprostate gland is removed through an incision in the lower abdomen orthe perineum. The procedure is used mostly in patients that have a large(greater than approximately 100 grams) prostate gland.

Minimally invasive procedures for treating BPH symptoms includeTransurethral Microwave Thermotherapy (TUMT), Transurethral NeedleAblation (TUNA), Interstitial Laser Coagulation (ILC), and ProstaticStents.

In Transurethral Microwave Thermotherapy (TUMT), microwave energy isused to generate heat that destroys hyperplastic prostate tissue. Thisprocedure is performed under local anesthesia. In this procedure, amicrowave antenna is inserted in the urethra. A rectal thermosensingunit is inserted into the rectum to measure rectal temperature. Rectaltemperature measurements are used to prevent overheating of theanatomical region. The microwave antenna is then used to delivermicrowaves to lateral lobes of the prostate gland. The microwaves areabsorbed as they pass through prostate tissue. This generates heat whichin turn destroys the prostate tissue. The destruction of prostate tissuereduces the degree of squeezing of the urethra by the prostate glandthus reducing the severity of BPH symptoms.

Another example of a minimally invasive procedure for treating BPHsymptoms is Transurethral Needle Ablation (TUNA). In this procedure,heat induced coagulation necrosis of prostate tissue regions causes theprostate gland to shrink. It is performed using local anesthetic andintravenous or oral sedation. In this procedure, a delivery catheter isinserted into the urethra. The delivery catheter comprises tworadiofrequency needles that emerge at an angle of 90 degrees from thedelivery catheter. The two radiofrequency needles are aligned at anangle of 40 degrees to each other so that they penetrate the laterallobes of the prostate. A radiofrequency current is delivered through theradiofrequency needles to heat the tissue of the lateral lobes to 70-100degree Celsius at a radiofrequency power of approximately 456 KHz forapproximately 4 minutes per lesion. This creates coagulation defects inthe lateral lobes. The coagulation defects cause shrinkage of prostatictissue which in turn reduces the degree of squeezing of the urethra bythe prostate gland thus reducing the severity of BPH symptoms.

Another example of a minimally invasive procedure for treating BPHsymptoms is Interstitial Laser Coagulation (ILC). In this procedure,laser induced necrosis of prostate tissue regions causes the prostategland to shrink. It is performed using regional anesthesia, spinal orepidural anesthesia or local anesthesia (periprostatic block). In thisprocedure, a cystoscope sheath is inserted into the urethra and theregion of the urethra surrounded by the prostate gland is inspected. Alaser fiber is inserted into the urethra. The laser fiber has a sharpdistal tip to facilitate the penetration of the laser scope intoprostatic tissue. The distal tip of the laser fiber has adistal-diffusing region that distributes laser energy 360° along theterminal 3 mm of the laser fiber. The distal tip is inserted into themiddle lobe of the prostate gland and laser energy is delivered throughthe distal tip for a desired time. This heats the middle lobe and causeslaser induced necrosis of the tissue around the distal tip. Thereafter,the distal tip is withdrawn from the middle lobe. The same procedure ofinserting the distal tip into a lobe and delivering laser energy isrepeated with the lateral lobes. This causes tissue necrosis in severalregions of the prostate gland which in turn causes the prostate gland toshrink. Shrinkage of the prostate gland reduces the degree of squeezingof the urethra by the prostate thus reducing the severity of BPHsymptoms.

Another example of a minimally invasive procedure for treating BPHsymptoms is implanting Prostatic Stents. In this procedure, the regionof urethra surrounded by the prostate is mechanically supported toreduce the constriction caused by an enlarged prostate. Prostatic stentsare flexible devices that are expanded after their insertion in theurethra. They mechanically support the urethra by pushing theobstructing prostatic tissue away from the urethra. This reduces theconstriction of the urethra and improves urine flow past the prostategland thereby reducing the severity of BPH symptoms.

Although existing treatments provide some relief to the patient fromsymptoms of BPH, they have disadvantages. Alpha-1a-adrenergic receptorsblockers have side effects such as dizziness, postural hypotension,lightheadedness, asthenia and nasal stuffiness. Retrograde ejaculationcan also occur. 5-alpha-reductase inhibitors have minimal side effects,but only a modest effect on BPH symptoms and the flow rate of urine. Inaddition, anti-androgens, such as 5-alpha-reductase, require months oftherapy before LUTS improvements are observed. Surgical treatments ofBPH carry a risk of complications including erectile dysfunction;retrograde ejaculation; urinary incontinence; complications related toanesthesia; damage to the penis or urethra, need for a repeat surgeryetc. Even TURP, which is the gold standard in treatment of BPH, carriesa high risk of complications. Adverse events associated with thisprocedure are reported to include retrograde ejaculation (65% ofpatients), post-operative irritation (15%), erectile dysfunction (10%),need for transfusion (8%), bladder neck constriction (7%), infection(6%), significant hematuria (6%), acute urinary retention (5%), need forsecondary procedure (5%), and incontinence (3%) Typical recovery fromTURP involves several days of inpatient hospital treatment with anindwelling urethral catheter, followed by several weeks in whichobstructive symptoms are relieved but there is pain or discomfort duringmicturition.

The reduction in the symptom score after minimally invasive proceduresis not as large as the reduction in symptom score after TURP. Up to 25%of patients who receive these minimally invasive procedures ultimatelyundergo a TURP within 2 years. The improvement in the symptom scoregenerally does not occur immediately after the procedure. For example,it takes an average of one month for a patient to notice improvement insymptoms after TUMT and 1.5 months to notice improvement after ILC. Infact, symptoms are typically worse for these therapies that heat or cooktissue, because of the swelling and necrosis that occurs in the initialweeks following the procedures. Prostatic stents often offer moreimmediate relief from obstruction but are now rarely used because ofhigh adverse effect rates. Stents have the risk of migration from theoriginal implant site (up to 12.5% of patients), encrustation (up to27.5%), incontinence (up to 3%), and recurrent pain and discomfort. Inpublished studies, these adverse effects necessitated 8% to 47% ofstents to be explanted. Overgrowth of tissue through the stent andcomplex stent geometries have made their removal quite difficult andinvasive.

Thus the most effective current methods of treating BPH carry a highrisk of adverse effects. These methods and devices either requiregeneral or spinal anesthesia or have potential adverse effects thatdictate that the procedures be performed in a surgical operating room,followed by a hospital stay for the patient. The methods of treating BPHthat carry a lower risk of adverse effects are also associated with alower reduction in the symptom score. While several of these procedurescan be conducted with local analgesia in an office setting, the patientdoes not experience immediate relief and in fact often experiences worsesymptoms for weeks after the procedure until the body begins to heal.Additionally all device approaches require a urethral catheter placed inthe bladder, in some cases for weeks. In some cases catheterization isindicated because the therapy actually causes obstruction during aperiod of time post operatively, and in other cases it is indicatedbecause of post-operative bleeding and potentially occlusive clotformation. While drug therapies are easy to administer, the results aresuboptimal, take significant time to take effect, and often entailundesired side effects.

Urinary Incontinence (UI)

Many women experience loss of bladder control following childbirth or inold age. This condition is broadly referred to as urinary incontinence(UI). The severity of UI varies and, in severe cases, the disorder canbe totally debilitating, keeping the patient largely homebound. It isusually associated with a cystocele, which results from sagging of theneck of the urinary bladder into or even outside the vagina

The treatments for UI include behavioral therapy, muscle strengtheningexercises (e.g., Kegel exercises), drug therapy, electrical stimulationof the pelvic nerves, use of intravaginal devices and surgery.

In severe cases of UI, surgery is generally the best treatment option.In general, the surgical procedures used to treat UI attempt to lift andsupport the bladder so that the bladder and urethra are returned totheir normal positions within the pelvic cavity. The two most commonways of performing these surgeries is through incisions formed in theabdominal wall or though the wall of the vagina.

A number of different surgical procedures have been used to treat UI.The names for these procedures include the Birch Procedure,Marshall-Marchetti Operation, MMK, Pubo-Vaginal Sling, Trans-VaginalTape Procedure, Urethral Suspension, Vesicourethral Suspension. Theseprocedures generally fall into two categories, namely a) retropubicsuspension procedures and b) sling procedures.

In retropubic suspension procedures, an incision is typically made inthe abdominal wall a few inches below the navel and a network of suturesare placed to support the bladder neck. The sutures are anchored to thepubic bone and to other structures within the pelvis, essentiallyforming a cradle which supports the urinary bladder.

In sling procedures, an incision is typically made in the wall of thevagina and a sling is crafted of either natural tissue or synthetic(man-made) material to support the bladder neck. Both ends of the slingmay be attached to the pubic bone or tied in front of the abdomen justabove the pubic bone. In some sling procedures a synthetic tape is usedto form the sling and the ends of the synthetic tape are not tied butrather pulled up above the pubic bone.

The surgeries used to treat UI are generally associated with significantdiscomfort as the incisions heal and may require a Foley or supra-pubicurinary catheter to remain in place for at least several days followingthe surgery. Thus, there exists a need in the art for the development ofminimally invasive (e.g., non-incisional) procedures for the treatmentof UI with less postoperative discomfort and less requirement forpost-surgical urinary catheterization.

Cosmetic or Reconstructive Tissue Lifting and Repositioning

Many cosmetic or reconstructive surgical procedures involve lifting,compressing or repositioning of natural tissue, natural tissue orartificial grafts or aberrant tissue. For example, surgical proceduressuch as face lifts, brow lifts, neck lifts, tummy tucks, etc. havebecome commonplace. In many cases, these procedures are performed bycreating incisions through the skin, dissecting to a plane beneathmuscles and fascia, freeing the muscles, fascia and overlying skin fromunderlying structures (e.g., bone or other muscles), lifting orrepositioning the freed muscles, fascia and overlying skin and thenattaching the repositioned tissues to underlying or nearby structures(e.g., bone, periostium, other muscles) to hold the repositioned tissuesin their new (e.g., lifted) position. In some cases excess skin may alsobe removed during the procedure.

There have been attempts to develop minimally invasive devices andmethods for cosmetic lifting and repositioning of tissues. For example,suture suspension lifts have been developed where one end of a standardor modified suture thread is attached to muscle and the other end isanchored to bone, periostium or another structure to lift and repositionthe tissues as desired. Some of these suture suspension techniques havebeen performed through cannulas or needles inserted though relativelysmall incisions of puncture wounds.

For example, barbed threads known as Aptos threads may be insertedthrough a hollow trocar and used to lift tissues of the face in aprocedure that is performed commercially under the name Featherlift™(KMI, Inc. 2550 West Rowland Anaheim, Calif. 92804).

Another barbed thread that is useable for minimally invasive cosmeticlifting procedures is marketed under the name Contour Threads™ (SurgicalSpecialties Corporation, 100 Dennis Drive Reading, Pa. 19606).

There remains a need for the development of new devices and methods thatmay be used for various procedures where it is desired to lift,compress, support or reposition tissues or organs within the body withless intraoperative trauma, less post-operative discomfort and/orshorter recovery times. Moreover, there is an opportunity to takeadvantage of aspects of anatomy and to employ structures configured tocooperate with such anatomy. In this way, an interventional site withina patient's body can be more easily accessed as well as heal more easilyand completely and the body can more readily return to normal operation.

The present invention addresses these and other needs.

SUMMARY OF THE INVENTION

Briefly and in general terms, the present invention is directed towardsan apparatus and method for deploying an anchoring assembly within apatient's body. The anchoring assembly can be configured to accomplishretracting, lifting, compressing, supporting or repositioning tissuewithin the body of a human or animal subject. Moreover, the apparatusconfigured to deploy the anchoring assembly as well as the anchoringassembly itself are configured to complement and cooperate with bodyanatomy. Further, the anchoring assembly may be coated or imbedded withtherapeutic or diagnostic substances or such substances can beintroduced into or near an interventional site by the anchor deploymentdevice or other structure.

In a particular aspect, the present invention includes an integratedanchor delivery device that is capable of deploying at an interventionalsite an anchoring assembly including a first anchoring member attachedby a connector to a second anchoring member. The anchor delivery devicefurther includes an extendable and retractable needle assembly as wellas structure to accomplish the deployment of the first anchoring memberlongitudinally through the needle assembly. The anchor delivery deviceadditionally includes structure to attach the second anchoring member tothe connector as well as cut the connector to a desired length.

In another aspect, structure of the anchoring assembly is designed toinvaginate within or complement tissue anatomy to thereby facilitatehealing and minimize infection risk. Moreover, the anchor deliverydevice includes structure to form desired angles between an extendedposition of the needle assembly relative to the device. Additionally, itis contemplated that a distal end portion of the anchor delivery devicebe configured to facilitate the testing of the effectiveness ofpositioning of an anchoring assembly. In this regard, the distal endportion is configured in a manner to mimic the effect a second anchoringmember will have prior to its implantation.

In one embodiment, the anchor delivery device includes a handle assemblywith a plurality of actuators or triggers attached thereto. A firstactuator is associated with a body of the handle assembly and isoperatively attached to the needle assembly and structure that advancesthe first anchoring member. A second actuator attached to the handleassembly is operatively associated with structure that accomplishesassembling first and second parts of the second anchoring member to eachother and to the connector member. Also, the handle assembly is equippedwith a third actuator that is configured in one contemplated embodiment,to effect the cutting of the anchoring assembly to a desired length anddeployment of the structure at an interventional site.

In a specific embodiment, the anchor delivery device includes agenerally elongate tubular housing assembly member extending distallyfrom a handle assembly including a plurality of actuators. The proximalend of the handle assembly is equipped with mounting structureconfigured to receive a telescope or other endoscopic viewinginstrument. A bore sized to receive the telescope extends distallythrough a body of the handle assembly and continues through an outertubular cover member forming the generally elongate member. Housedwithin the tubular housing assembly are a telescope tube having aninterior defining a distal section of the bore sized to receive thetelescope, an upper tubular member assembly sized to receive a pluralityof first components of the second anchor member and a needle housingconfigured to receive the needle assembly. Moreover, the generallyelongate tubular housing includes a terminal end portion defined by anose assembly which retains a plurality of second components of thesecond anchoring members.

Moreover, in a preferred embodiment the first anchor member includes abody having a generally tubular portion from which a first partialcylinder portion extends proximally. Attached to a midpoint of the bodyis a spring in the form of a second partial cylinder portion that iscomplementary to the first partial cylinder portion. Extending from theopposite end of the spring is a generally tubular collar. In acompressed configuration, the first anchor member defines a generallystraight member and when unconstrained, the first anchor member forms aT-structure with the body defining the cross-member of the T-structure.

Further, in the preferred embodiment, the first part of the secondanchoring member is embodied in a pin having a first distal end equippedwith a pair of spaced arms and a second proximal end including groovesfacilitating pushability. The arms of the first distal end are designedto receive the connector structure and to be placed into lockingengagement with the second part of the second anchoring member. Thesecond part has a generally tubular configuration and an internal boresized to receive the first component.

The present invention also contemplates a number of alternative designsfor the first and second anchoring members and connectors as well asstructures for advancing and deploying the anchoring members and cuttingthe connector. Additionally, it is contemplated that various embodimentscan incorporate one or more sensors into the deployment device tofacilitate proper positioning of the device and anchor deployment.

Moreover, various alternative methods of use are also contemplated. Thatis, in some applications of the invention, the invention may be used tofacilitate volitional or non-volitional flow of a body fluid through abody lumen, modify the size or shape of a body lumen or cavity, treatprostate enlargement, treat urinary incontinence, support or maintainpositioning of a tissue, organ or graft, perform a cosmetic lifting orrepositioning procedure, form anastomotic connections, and/or treatvarious other disorders where a natural or pathologic tissue or organ ispressing on or interfering with an adjacent anatomical structure. Also,the invention has a myriad of other potential surgical, therapeutic,cosmetic or reconstructive applications, such as where a tissue, organ,graft or other material requires retracting, lifting, repositioning,compression or support.

Other features and advantages of the present invention will becomeapparent from the following detailed description, taken in conjunctionwith the accompanying drawings, which illustrate, by way of example, theprinciples of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an elevation view, depicting an integrated anchor deploymentdevice;

FIG. 2A is a cross-sectional view, depicting a distal end portion of thedevice of FIG. 1;

FIG. 2B is a cross-sectional view, depicting the implantation ofanchoring assemblies at an interventional site;

FIG. 2C is an enlarged view, depicting one anchoring component of theassemblies shown in FIG. 2B;

FIG. 2D is a partial perspective view, depicting an elongate tubeassembly of the device of FIG. 1 without the outer sheath and detachedfrom the nose assembly and handle assembly;

FIG. 2E is a cross-sectional view, depicting a portion of a handleassembly of the device of FIG. 1;

FIG. 2F is a cross-sectional view, depicting further details of thedevice of FIG. 2C in addition to a cross-sectional view of a portion ofthe tubular housing assembly;

FIG. 3A is a perspective view, depicting a first anchoring member of ananchoring assembly of the present invention shown in a substantiallystraight configuration;

FIG. 3B is a perspective view, depicting the first member of FIG. 3A ina deployed or flipped configuration;

FIG. 3C is a perspective view, depicting a first component of a secondanchoring member of an anchoring assembly of the present invention;

FIG. 3D is a perspective view, depicting a second component of a secondanchoring member of an anchoring assembly of the present invention;

FIG. 3E is a perspective view, depicting a connector component with aplurality of first anchoring members of the anchoring assembly disposedthereon;

FIG. 3F is a perspective view, depicting an assembled anchoringassembly;

FIG. 3G is a perspective view, depicting a coined connector;

FIG. 3H is a perspective view, depicting a connector equipped withraised portions;

FIG. 3I is a perspective view, depicting a connector equipped withcrimped components;

FIG. 4A is a perspective view, depicting an alternate embodiment of adistal component of an anchoring assembly;

FIG. 4B is a perspective view, depicting the distal component of FIG. 4Ain a flipped configuration;

FIG. 4C is a perspective view, depicting another alternate embodiment ofa distal component of an anchoring assembly;

FIG. 4D is a perspective view, depicting the distal component of FIG. 4Cin a flipped configuration;

FIG. 4E is a perspective view, depicting yet another alternateembodiment of a distal component of an anchoring assembly;

FIG. 4F is a perspective view, depicting the distal component of FIG. 4Ein a flipped configuration;

FIG. 4G is a perspective view, depicting a distal component of ananchoring assembly with a first embodiment of a tail section;

FIG. 4H is a perspective view, depicting a distal component of ananchoring assembly with a second embodiment of a tail section;

FIG. 4I is a perspective view, depicting a distal component of ananchoring assembly with a third embodiment of a tail section;

FIG. 4J is a perspective view, depicting yet another embodiment of adistal component;

FIG. 5A is a cross-sectional view, depicting a first step of treating aprostate gland using the present invention;

FIG. 5B is a cross-sectional view, depicting a portion of the anchordeployment device of FIG. 1 with the first actuator pivoted toward thehandle assembly;

FIG. 5C is a cross-sectional view, depicting further internal mechanismsof the handle for accomplishing the advancement of the needle assembly;

FIG. 5D is a perspective view, depicting the distal end portion of theanchor deployment device and the lateral advancement of a needleassembly;

FIG. 5E is a cross-sectional view, depicting a second step of treating aprostate gland using the present invention;

FIG. 5F is a perspective view, depicting the partial retraction of theneedle assembly;

FIG. 5G is a cross-sectional view, depicting the assembly of FIG. 5D;

FIG. 5H is a perspective view, depicting the complete retraction of theneedle assembly;

FIGS. I and J are cross-sectional views, depicting further steps of amethod of treating a prostate gland using the present invention;

FIG. 5K is an enlarged perspective view, depicting one embodiment of afeeding mechanism for the distal component;

FIG. 6A is an elevation view, depicting one alternative approach forcontrolling the advancement and deployment of an anchor component;

FIG. 6B is an elevation view, depicting a first configuration of theanchor of FIG. 6A after release from the advancement substructure.

FIG. 6C is an elevation view, depicting a second configuration of theanchor of FIG. 6A after release from the advancement substructure.

FIG. 6D is a perspective view, depicting an alternate embodiment of apusher device;

FIG. 6E is a perspective view, depicting a needle and pusher assemblyconfigured for side loading of an anchor component;

FIG. 6F is a perspective view, depicting an alternate embodiment of apusher assembly;

FIG. 6G is a perspective view, depicting the pusher assembly of FIG. 6Fand a complementary needle assembly;

FIG. 7A is a cross-sectional view, depicting an anchor loaded in aprotective cover;

FIG. 7B is a cross-sectional view, depicting a pusher cartridge in aloaded position;

FIG. 7C is a cross-sectional view, depicting the cartridge of FIG. 7A inan anchor deployed position;

FIG. 7D is an elevation view, depicting an anchor cartridge assembly;

FIG. 7E is a perspective view, depicting a needle assembly equipped witha sensor;

FIG. 8A is a cross-sectional view, depicting the pivoting of the secondactuator with respect to the handle;

FIG. 8B is an isometric view, depicting internal components operativelyassociated with the second actuator and with other components of theanchor deployment device removed;

FIG. 8C is a partial cross-sectional view, depicting a distal endportion of the integrated anchor deployment device of FIG. 8A;

FIG. 8D is a partial cross-sectional view, depicting the deploymentdevice of FIG. 8C with a second component of the second anchoring memberbeing advanced toward a first component of the second anchoring member;

FIG. 8E is a perspective view, depicting the deployment device of FIG.8B with the second component completely advanced into locking engagementwith the first component;

FIG. 9A is an enlarged perspective view, depicting a first step injoining the first and second components of the second anchoring member;

FIG. 9B is an enlarged perspective view, depicting a second step injoining the first and second components of the second anchoring member;

FIG. 9C is an enlarged perspective view, depicting a third step injoining the first and second components of the second anchoring member;

FIG. 9D is an enlarged perspective view, depicting a first step in analternate approach in joining the first and second components of thesecond anchoring member;

FIG. 9E is an enlarged perspective view, depicting a second step in thealternate approach in joining the first and second components of thesecond anchoring member;

FIG. 9F is an enlarged perspective view, depicting a third step in thealternate approach in joining the first and second components of thesecond anchoring member;

FIG. 9G is a perspective view, depicting another alternate embodiment ofthe first and second components of the second anchoring member;

FIG. 9H is a cross-sectional view, depicting an interior of the assemblyshown in FIG. 9G;

FIG. 9I is a perspective view, depicting yet another alternativeembodiment of the first and second components of the second anchoringmember;

FIG. 9J is a perspective view, depicting yet another embodiment of thesecond anchoring member;

FIG. 9K is a perspective view, depicting a further embodiment of thesecond anchoring member;

FIG. 9L is a perspective view, depicting yet a further embodiment of thesecond anchoring member;

FIG. 9M is a perspective view, depicting another embodiment of thesecond anchoring member;

FIG. 9N is a perspective view, depicting another embodiment of thesecond anchoring member;

FIG. 9O is a perspective view, depicting another embodiment of thesecond anchoring member;

FIG. 9P is a perspective view, depicting the embodiment of FIG. 9O in anassembled form;

FIG. 9Q is a perspective view, depicting another embodiment of thesecond anchoring member;

FIG. 9R is a perspective view, depicting the embodiment of FIG. 9Q in anassembled form;

FIG. 9S is a perspective view, depicting another embodiment of thesecond anchoring member;

FIG. 9T is a perspective view, depicting another embodiment of thesecond anchoring member;

FIG. 9U is a perspective view, depicting the embodiment of FIG. 9T in anassembled form;

FIG. 9V is a perspective view, depicting another embodiment of thesecond anchoring member;

FIG. 9W is a perspective view, depicting the embodiment of FIG. 9V in anassembled form;

FIG. 9X is a perspective view, depicting another embodiment of thesecond anchoring member;

FIG. 9Y is a perspective view, depicting another embodiment of thesecond anchoring member;

FIG. 9Z is a perspective view, depicting another embodiment of thesecond anchoring member;

FIG. 9AA is a perspective view, depicting another embodiment of thesecond anchoring member;

FIG. 9AB is a perspective view, depicting another embodiment of thesecond anchoring member;

FIG. 9AC is a perspective view, depicting the embodiment of FIG. 9AC ina compressed form;

FIG. 9AD is a perspective view, depicting another embodiment of thesecond anchoring member;

FIG. 9AE is a perspective view, depicting the embodiment of FIG. 9AD ina compressed form;

FIG. 9AF is a perspective view, depicting another embodiment of thesecond anchoring member;

FIG. 9AG is a perspective view, depicting another embodiment of thesecond anchoring member;

FIG. 9AH is a perspective view, depicting the embodiment of FIG. 9AG inan open configuration;

FIG. 9AI is a perspective view, depicting another embodiment of thesecond anchoring member in combination with a forming anvil;

FIG. 9AJ is a perspective view, depicting another embodiment of thesecond anchoring member in combination with a forming anvil;

FIG. 9AK is a perspective view, depicting another embodiment of thesecond anchoring member;

FIG. 9AL is a perspective view, depicting another embodiment of thesecond anchoring member;

FIG. 9AM is a perspective view, depicting the embodiment of FIG. 9AL inan open configuration;

FIG. 9AN is a perspective view, depicting another embodiment of thesecond anchoring member shown in its flattened configuration;

FIG. 9AO is a perspective view, depicting another embodiment of thesecond anchoring member shown in its flattened configuration;

FIGS. 10A-B are cross-sectional views, depicting yet further stepsinvolved in treating a prostate gland using the present invention;

FIG. 11A is a cross-sectional view, depicting a first step in analternative approach to anchor assembly and deployment;

FIG. 11B is a cross-sectional view, depicting a second step in analternative approach to anchor assembly and deployment;

FIG. 11C is a cross-sectional view, depicting a third step in analternative approach to anchor assembly and deployment;

FIG. 12A is a perspective view, depicting structure configured to aligncomponents of the anchoring assembly;

FIG. 12B is a cross-sectional view, depicting the structure of FIG. 12A;

FIG. 13A is a partial cross-sectional view, depicting a first step in analternative approach to implanting an integrated anchor assembly;

FIG. 13B is a partial cross-sectional view, depicting a second step inan alternative approach to implanting the integrated anchor assembly ofFIG. 13A;

FIG. 13C is a perspective view, depicting a third step in an alternativeapproach to implanting the integrated anchor assembly of FIG. 13A;

FIG. 13D is a perspective view, depicting yet another embodiment of anintegrated anchor;

FIG. 13E is an elevation view, depicting the anchor of FIG. 13D in aflipped configuration;

FIG. 13F is an elevation view, depicting the anchor of FIG. 13D in aflat configuration.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Turning now to the figures, which are provided by way of example and notlimitation, the present invention is embodied in a device configured todeliver anchor assemblies within a patient's body. As stated, thepresent invention can be employed for various medical purposes includingbut not limited to retracting, lifting, compressing, supporting orrepositioning tissues, organs, anatomical structures, grafts or othermaterial found within a patient's body. Such tissue manipulation isintended to facilitate the treatment of diseases or disorders. Moreover,the disclosed invention has applications in cosmetic or reconstructionpurposes or in areas relating the development or research of medicaltreatments.

In such applications, one portion of an anchor assembly is positionedand implanted against a first section of anatomy. A second portion ofthe anchor assembly is then positioned and implanted adjacent a secondsection of anatomy for the purpose of retracting, lifting, compressing,supporting or repositioning the second section of anatomy with respectto the first section of anatomy. It is also to be recognized that both afirst and second portion of the anchor assembly can be configured toaccomplish the desired retracting, lifting, compressing, supporting orrepositioning of anatomy due to tension supplied thereto via a connectorassembly affixed to the first and second portions of the anchorassembly.

Referring now to FIG. 1, there is shown one embodiment of an integratedanchor delivery device 20. This device is configured to includestructure that is capable of both gaining access to an interventionalsite as well as assembling and implanting an anchoring device within apatient's body. The device further includes structure configured toreceive a conventional remote viewing device so that the steps beingperformed at the interventional site can be observed.

The integrated anchor delivery device 20 includes a handle assembly 22and a tubular housing assembly 24 extending from the handle assembly 22.The handle assembly 22 is sized and shaped to fit comfortably within anoperator's hand and can be formed from conventional materials.

The proximal end of the delivery device 20 includes a mount 26 forreceiving an endoscope or telescope 28 or other imaging device. Themount 26 includes an internal bore (not shown) sized and shaped toreceive the telescope 28. As indicated, the telescope 28 is intended toprovide the operator with the ability to view the operation of thedelivery device 20 at an interventional site.

The handle assembly 22 of the delivery device 20 also includes aplurality of activators or triggers associated with the handle assembly22. The body 30 includes a first or upper portion 32 extending generallyperpendicularly with respect to a second or lower portion 34. The secondportion is intended to be sized and shaped to fit within the palm of anoperator's hand. Pivotably affixed to the second portion 34 is a firstactuator 36. Although it can come in a myriad of forms, the firstactuator 36 includes a hooped portion sized and shaped to receive one ormore fingers of the operator's hand. The hooped portion extends from anarm which is pivotably connected to the handle 22, the arm and hoopedportion defining an acute angle with respect to the second portion 34 ofthe handle assembly 22 when inactivated. As will be described in moredetail below, the first actuator 36 is operatively associated with aneedle assembly and structure configured to advance and place a firstcomponent of an anchoring assembly at an interventional site.

A second trigger or actuator 38 is pivotably connected adjacent thefirst body portion 32. Although it can come in a myriad of forms, thesecond actuator 38 defines a generally finger-like projection and ispositioned longitudinally distally from the body 30 with respect to thefirst actuator 36. The second actuator 38 also defines an acute anglerespecting the second portion 34 of the handle assembly 22 and is sizedand shaped to comfortably receive one or more fingers of the operator.Upon actuation, the second actuator 38 is configured to accomplish theassembly of an anchoring device by attaching a second anchor componentto a connector affixed to the first anchor component.

A third trigger or actuator 40 is connected and configured to pivotablyrotate with respect to a top side of upper body portion 30. Although itcan come in a myriad of forms, in one embodiment, the third actuator 40defines a relatively straight member with a rounded substructure formedat its free terminal end. In this way, the third actuator 40 is easilymanipulated by a free digit of the operator's hand. The third actuator40 rotates from a forward position where it forms an acute angle withthe tubular housing assembly 24 to a rearward position where the memberdefines an obtuse angle with respect to the tubular housing assembly 24.In one embodiment, the third actuator 40 is intended to retract portionsof the tubular housing assembly 24 as well as accomplish cutting theconnector of the anchoring assembly and deploying the anchoring assemblyat an interventional site.

As stated, the tubular housing assembly 24 extends from the handleassembly 22. In one aspect, the tubular housing assembly 24 is mountedto a front face of the upper portion 32 of the handle assembly 22 andextends parallel to a longitudinal axis of the upper portion 32. At itsproximal end, the tubular housing assembly 24 includes a mount 42 fromwhich an outer sheath 44 extends in a distal direction. The mount 42includes one or more conventional stop cock assemblies 46 which providefluid communication with an interior of the tubular housing assembly.One stop cock assembly 46 is intended to provide the anchor deliverydevice 20 with a continuous flow irrigation. Another stop cock 46 iscontemplated to be used to accomplish a suction function through thedevice. Either of these assemblies can further be employed to delivertherapeutic or diagnostic substances to the interventional site. Forexample, in a procedure to treat a prostate gland, substances that causethe prostate to decrease in size such as 5-alpha-reductase inhibitorscan be introduced at the treatment site. Other substances but notlimited thereto, which may be introduced at the site include variousphytochemicals, alpha-1a-adrenergic receptor blocking agents, smoothmuscle relaxants and other agents that inhibit the conversion oftestosterone to dihydrotestosterone.

A terminal end portion 48 of the tubular housing assembly 24 of theanchor deployment device 20 includes a nose assembly 50 shaped toprovide an atraumatic surface as well as one which facilitates desiredpositioning of components of an anchoring assembly (See FIG. 2A). Thatis, by including structure that can mimic the ultimate position of aproximally oriented component of an anchoring assembly, an operator cantest the effect of the anchoring assembly prior to implantation. Oncethe operator confirms that the subject anchoring component will bepositioned as desired, the implantation of the anchor is then undertakenand accomplished.

Once implanted, the anchoring assembly 51 (See FIGS. 2B and C) of thepresent invention accomplishes desired tissue manipulation or retractionas well as cooperates with the target anatomy to provide an atraumaticsupport structure. In particular, as shown in FIG. 2C, the shape andcontour of the anchoring assembly 51 can be configured so that theassembly invaginates within target tissue, such as within natural foldsformed in the urethra by the opening of the urethra lumen by theanchoring assembly. In fact, in situations where the anchor assembly isproperly placed, wispy or pillowy tissue in the area collapses aroundthe anchor structure. Eventually, the natural tissue can grow over theanchor assembly 51 and new cell growth occurs over time in the areasshown in FIG. 2C. Such cooperation with target tissue facilitateshealing and avoids unwanted side effects such as calcification at theinterventional site.

Furthermore, in addition to an intention to cooperate with naturaltissue anatomy, the present invention also contemplates approaches toaccelerate healing or induce scarring. Manners in which healing can bepromoted can include employing abrasive materials, textured sutures,biologics and drugs.

It has been observed that placing the anchors at various desiredpositions within anatomy can extract the best results. For example, whentreating a prostate, one portion of an anchor can be placed within anurethra. It has been found that configuring such anchors so that teno'clock and two o'clock positions are supported or retained effectivelyholds the anatomy open and also can facilitate invagination of theanchor portion within natural tissue. This is particularly true in theregions of anatomy near the bladder and the juncture at which theejaculatory duct connects to the urethra.

Additionally, the terminal end portion 48 (FIG. 2A) includes a pluralityof spring biased, vertically stacked ring anchor components 52strategically positioned with respect to telescoping structure of thetubular housing assembly for the purpose of assembling an anchoringdevice. As will be apparent from further description below, the stackedanchor component 52 is one of two parts which form a second anchorcomponent. To accomplish the biasing of the anchor components 52, a leafspring 54 is placed in apposition with the anchor component 52 that isat the bottom of the stack of components. Internal molded walls andbosses of the nose assembly 48 form a space to both receive the stackedanchor components 52 as well as provide an area to retain the leafspring 54 and provide a base structure against which force supplied bythe leaf spring can be generated and transmitted to the anchorcomponents 52.

As can be seen from FIG. 2A, terminal end portions of an upper tubularmember 56, a needle housing 58 and a telescope housing 60 are positionedwithin the nose assembly. Referring now to FIG. 2D, one can better seethe internal components forming the tubular housing assembly. Forrepresentation purposes, the outer sheath 44 is not depicted in FIG. 2Aand the internal components of the tubular housing assembly are shownseparate from the nose assembly and handle assembly. As shown, the uppertubular member 56, the needle housing 58 and telescope housing 60 extendlongitudinally. The outer sheath (not shown in FIG. 2A) covers asubstantial length of each of the upper tubular member 56, needlehousing 58 and telescope housing 60. Each of these structures alsoinclude internal bores, the upper tubular member 56 sized to slideablyreceive a pusher assembly (described in more detail below) and theneedle housing 58 sized to slideably receive a needle assembly 58 (alsodescribed in more detail below). Further, the telescope housing 60 issized to receive a conventional telescope (not shown), which in oneapproach, fills the entire space provided by the internal bore of thehousing 60. A cross-sectional view of a portion of the tubular housingassembly attached to the handle assembly 22 (with the nose assemblyremoved) is shown in FIG. 2F.

Turning now to FIGS. 2E and 2F, the internal components of the handleassembly will be described. In one preferred embodiment, the handleassembly 22 houses a needle assembly advancement and retractionsubassembly 66 that interacts with the movement of the first actuator.The first actuator includes a projection 68 extending through thehousing assembly 22 and is placed in operative association with theadvancement and retraction subassembly 66.

The needle assembly advancement and retraction subassembly 66 includesan outer collar 70 configured about an inner collar 72. Configuredbetween the outer collar 70 and an internal front surface 74 of thehandle assembly 22 is a first compressor spring 75. Placed within theouter collar 68 and between the inner collar 72 and an internal frontsurface 76 is a second compression spring 77. Additionally, attached tothe outer collar 70 is a lock assembly 78 which rotates between lockedand unlocked positions.

While the first actuator is in an open position (See FIG. 1), thecompression springs 75, 76 assume expanded configurations (See FIGS. 2Eand F). Also, the lock assembly 78 is in a disengaged or unlockedconfiguration. It is at this stage that the needle assembly (describedbelow) is in its retracted state and housed completely within the needlehousing 58.

One preferred embodiment of a first or distal component 82 is shown inFIGS. 3A and 3B. In an unconstrained configuration, the first componentforms a generally T-configuration (FIG. 3B). When constrained within ananchor delivery device, the first component defines a substantiallystraight member (FIG. 3A). While the component can be formed from anumber of materials and manufactured using various conventionalapproaches, it is contemplated that the component 82 be cut from anitinol tube using a laser. Using a superelastic material such asnitinol provides the component 82 with the resiliency to transformbetween a flipped T-configuration and a straight configuration.

As shown, the first component 82 includes a first portion 84 which atone end defines a cylindrical structure and at the other a partialcylindrical structure. When unconstrained, this first portion 84 forms aT-bar or top of the first component 82. A complementary partialcylindrical structure forms a mid-section or second portion 86 of thefirst component 82 and operates as a spring to accomplish the flippingof the first portion 84 between constrained and unconstrainedconfigurations. When the component is in its constrained, straight form,the second portion is positioned adjacent the first portion 84. A thirdportion 88 is also cylindrical in shape and extends from the secondportion 86 away from the first portion 84 of the first anchor component82. The third portion 88 slides freely with respect to a connector, theconnector being attached to the first portion 84 and a second anchorcomponent as will be described below.

One part of the second anchoring component 52 is best seen in FIG. 3C(previously depicted as stacked anchor components in FIG. 2A). Thiscomponent is generally cylindrical in form and includes integrallyformed rings 90 spaced along an outer surface of the device, suchspacing can be varied as necessary for a particular purpose. The devicefurther includes a internal bore 92 which extends the entire lengththereof. A proximal end 93 of this part of the second anchoringcomponent 52 includes an opening to the internal bore 92. The opening tothe bore 92 is surrounded by a first ring 90 and is sized to receive ina locking arrangement the connector which will attach the first anchor82 to the second anchor component 52. Additional rings 90 are spacedlongitudinally along an outside surface of the component.

As shown in FIG. 3D, a second part 98 of the second anchoring component52 can be sized and shaped to both engage a connector and to lockinglyengage the first part. Although various forms of the second part 98 arecontemplated and described below, in one approach, the second part isgenerally cylindrical and includes a pair of spaced arms, the outerprofile being sized to fit within the internal bore 92 of the firstpart.

The connector 94 (See FIG. 3E) can be formed from any material whichprovides the desired holding force between first and second components.In one preferred embodiment, the connector is formed from conventionalsuture material for example monofilament polyester. In a preferredembodiment, the connector 94 is monofilament polyethylene terephthalate(PET). The suture material embodies desirable flexibility as well astensile strength. The monofilament PET size 2-0 is preferred because ofhigh tensile strength when tensioned and high column strength to pushthe series of parts 82 through and out the needle. In addition, themonofilament helps reduce or eliminate the possibility of infection. Assuch, when used as a connector 94, such material can be flexed at sharpangles to access various anatomical structures and surfaces and can alsobe relied upon to transmit necessary forces between the first and secondanchoring assemblies. One or more first anchor components 82 can beaffixed along a length of the connector 94. Further, various approachescan be employed to attach a first anchor component 82 to the connector.For example, the components can be affixed by an adhesive or can includetabs or other structure which is deformed into a locking arrangementwith the connector 94. Moreover, the anchor component 82 can simply becrimped directly to the connector 94 or the connector itself can includestructure which is complementary to that of the component to accomplishaffixation. It may be advantageous to employ an assembly capable ofhandling a connector equipped with a plurality of anchor componentsspaced along the connector since such a system has the ability toassemble and deliver multiple anchor assemblies without needing toreload.

One embodiment of a completely assembled anchoring assembly 92 isdepicted in FIG. 3F. In the embodiment shown, the assembly includes asingle first anchor component 82. In certain applications, however, itmay be desirable to employ a device having a plurality of spaced firstanchor components. Such spacing can be varied as desired for aparticular application.

It is also contemplated that the completed anchor assembly is formedfrom components which are held together magnetically. For example, thefirst anchor component 82 and the second anchor component 52, 98 can beheld in place through magnetism and without the need of a connector. Insuch an approach, either both or one of the anchor components can be amagnet.

Moreover, as can be seen from FIG. 3F, the second anchor componentembodies the first part 52 which can be deployed from the stacked groupof such members housed within the terminal end portion 48 of the tubularhousing assembly 24 (See FIG. 2A), as well as the second part 98 which,by operation of the anchor delivery device 20 (described below),lockingly engages the first part 52.

As previously mentioned, a completed anchor assembly 96 can be employedto manipulate tissue and other structure found within a patient's bodyfor various purposes. In order to do so, the first anchoring component82 is initially positioned in an apposition with a first body structure,such as the outer surface of the prostate capsule, and the secondanchoring component assembly (52, 98) is placed against a second bodystructure, such as the inner surface of the urethra, the connector 94holding the desired spacing between the two body structures toaccomplish the desired manipulation.

Additionally, it is contemplated that all components of the anchorassembly 96 or selected portions thereof (of any of the anchorassemblies described or contemplated), may be coated or embedded withtherapeutic or diagnostic substances (e.g. drugs or therapeutic agents).Again, in the context of treating a prostate gland, the anchor assembly96 can be coated or imbedded with substances such as 5-alpha-reductasewhich cause the prostate to decrease in size. Other substancescontemplated include but are not limited to phytochemicals generally,alpha-1a-adrenergic receptor blocking agents, smooth muscle relaxants,and agents that inhibit the conversion of testosterone todihydrotestosterone. In one particular approach, the connector 95 canfor example, be coated with a polymer matrix or gel coating whichretains the therapeutic or diagnostic substance and facilitatesaccomplishing the timed release thereof. Additionally, it iscontemplated that bacteriostatic coatings can be applied to variousportions of the anchoring assemblies described herein. Such coatings canhave various thicknesses or a specific thickness such that it along withthe connector itself matches the profile of a cylindrical portion of ananchor member affixed to the connector. Moreover, the co-delivery of atherapeutic or diagnostic gel or other substances through the implantdeployment device or another medical device (i.e. catheter), andmoreover an anchor assembly including the same, is contemplated. In onesuch approach, the deployment device includes a reservoir holding thegel substance and through which an anchoring device can be advance topick up a desired quantity of therapeutic or diagnostic gel substance.

The connector 94 can have associated therewith various structures whichfacilitate the attachment of anchoring structures. Although intended forthe first anchor component 82, such structure can also be used for thesecond anchor component 52, 98. In one approach (FIG. 3G), the connector94 is coined 100 in a manner that provides structure to which an anchormember can form a locking engagement. As shown in FIG. 3H, structurefacilitating a locking engagement with anchor structure also can also bein the form of a ball-chain 102. Furthermore, a connector 94 can beequipped with crimped metal or other structures 104 for this purpose.

Turning now to FIGS. 4A-4I, various alternatives of first anchorcomponents 82 are presented. In particular, those depicted in FIGS. 4A-Ieach include a structure which flips to assume an angled or generallylateral configuration when the component is unconstrained. In aconstrained configuration, these components define a generallycylindrical profile (as shown in FIG. 4A).

Moreover, each of the various alternative embodiments can be formed fromconventional materials. In one aspect, the components can be formed bylaser cutting a nitinol tube. However, it is to be recognized that othermaterials and manufacturing approaches are also contemplated for exampleEDM of stainless steel.

For example, the connector shown in FIG. 4A includes a proximallyoriented collar 106 which is intended to be slid along a connector asthe second portion flips or rotates. A spring member 86 defines a bararm which forms a bridge between the collar 106 and a second portion 108which flips or rotates with respect to the collar 106 when the device isunconstrained as shown in FIG. 4B. In another approach (FIGS. 4C and4D), the spring member 86 forms a bridge between the collar 106 and asecond portion 108 which includes a pair of members which in aconstrained configuration extend in opposite directions along theconnector 94 and when unconstrained, form a T-bar structure. In yetanother approach (FIGS. 4E-F), the anchoring component 82 can include apair of collars 106 configured between which are first and secondsprings 86. Attached to each spring 86 is a second portion 108, each ofwhich assume angled or lateral positions to thereby form an overallcross-like structure when unconstrained. Like the other embodiments, thecomponent defines a generally straight, cylindrical structure whenconstrained.

FIGS. 4G-I depict further embodiments of structures that can be employedas first anchoring components 82 or alternatively, can be used solely asstructures for advancing the anchoring assembly sub-components withinthe anchor delivery device or a patient's body. Each of these depictedstructures include various forms of tails 110 which can be employed toadvance the anchor components 82 through direct engagement with aterminal end of a pusher assembly (not shown) or for registering withinslots formed in a pusher assembly. These tails also help to flip, turnor angle the component 82 relative to connector 94. One embodiment ofthe tail (FIG. 4G) is a simple extension of a partial cylindrical memberwhich is bent away from the connector 94. Another approach (FIG. 4H)involves a long tail 110 which is folded against the connector 94 andyet another approach (FIG. 4I) involves a tail 110 that rather thanfolded against the connector includes a narrowed section which is bentaway from the connector and terminates to assume a beaver tail-likeshape.

With reference now to FIG. 4J, yet another embodiment of a firstanchoring component 82 is presented. In this embodiment, the firstanchoring component includes a full tube portion 107 connected to a halftube portion 109 by a coiled portion 111. The device can further includesuture attachment points formed along the full tube portion 109. Thecoiled portion 111 provides flexibility in multiple planes and thusfacilitates pushing the device through bends or angles formed in thedeployment device employed to deliver the first anchoring component 82.

In a first step to deliver and deploy an anchoring assembly for thepurpose of manipulating tissue or other anatomical structures, thetelescope device is employed to view the positioning of the device 20 atthe interventional site, for example, the tubular housing assembly 24 ofthe device is inserted into the penis of a patient and advanced untilthe distal end 48 is adjacent an interventional site in the urethra (UT)adjacent the bladder (UB; See FIG. 5A). It has been found that amechanical solution to the treatment of BPH such as that of the presentinvention, can be more compatible with patients recovering from prostatecancer compared to energy-based solutions. Furthermore, the presentinvention also contemplates steps for sizing the anatomy. As it relatesto BPH treatment, the present invention also involves the placement ofan ultrasonic or other device in the patient's body, such as in therectum, to measure the necessary depth of insertion of the anchordeployment device within the patient's body. This information can beused to set or create a depth stop for the needle assembly so that theoperator can readily determine whether desired sections of the patient'sanatomy have been accessed. After so positioning the deployment devicewithin the patient, the first actuator 36 of the delivery device 20 (SeeFIG. 1) is then caused to be pivoted towards the handle assembly 22.Doing so causes the needle assembly 112 to be advanced distally and thenlaterally through a terminal end of the needle housing 58. The lockassembly 78 retains the needle in the advanced configuration (See FIGS.5C and D). It is to be noted that the lock assembly 78 can be configuredto automatically unlock or to require manipulation to disengage from alocking position. In a procedure to treat the prostate gland (PG) theneedle assembly 112 is advanced through the prostate gland to a firstimplant position (See FIG. 5E). Moreover, it is to be recognized thatfirst forked member 113 is translatable longitudinally either by hand orthrough action of a trigger or activator. In FIG. 5D, the first forkedmember 113 is shown retracted to more easily represent other systemcomponents, but in use, at this stage of deployment, the member 113 iscontemplated to be in an advanced position into engagement with slot115. Further, it is to be understood that for ease of systemrepresentation, second forked member 119 is shown in a truncated form,in that at this stage of deployment the terminal end of the member 119extends beyond the vertical stack of second anchor components 52,thereby holding the stack in a staged configuration. Finally, thepresent invention also contemplates a single member replacing the forkedmembers 113, 119 depicted, such a part of member 56 which can haveportions which provide the function accomplish by the terminal ends ofthe members 113, 119.

Notably, the needle assembly 112 has a generally tubular shape andterminates with a sharp point 114. A lumen extending the length of theneedle assembly 112 is sized to receive both components of the anchoringassembly as well as structure for advancing the assembly through and outof the terminal end 114. Although various materials are contemplated,the needle assembly 112 is intended to be formed from resilient materialsuch as nitinol or other materials or polymeric substances. Moreover,although various angles are contemplated, in one approach the needlehousing 58 includes a distal section angled such that the needleprojects at angles approaching or at 90 degrees with respect to alongitudinal axis of the tubular housing assembly 24.

Once access is made at an interventional site to target tissue oranatomical structure and the first actuator is manipulated to advancethe needle assembly 114 to a desired position, the actuator is furthermanipulated to release the lock assembly 78 as well as to cause theinternal compression springs to retract the needle assembly. Note thatthe position of the first actuator 36 will return to the open position(See FIGS. 1, 2E and 2F). The result of this action is depicted in FIGS.5F, G, H, I and J. (Again, note that member 113 and 119 are shown inretracted or truncated forms in FIGS. 5F, G and H for clarity ofrepresentation.) That is, as the needle assembly 112 is refracted, thefirst anchoring component 82 and connector 94 remain in an advancedconfiguration (FIGS. 5I and J). It is at this stage that the firstanchoring component has been positioned as desired against a firstanatomical body structure (See FIG. 5J).

Contemporaneously with the retraction of the needle assembly 112, is thewithdrawal of the structure used to advance the first anchoringcomponent 82 and connector structure 94 within the needle housing 58. Inone embodiment (See FIG. 5K), the advancing structure is in the form ofa pusher assembly 116. The pusher 116 can assume a generally cylindricaltube formed form a metallic or polymeric material which is sized andshaped to directly engage the first anchoring component 82. Moreover,the pusher 116 could define a solid elongate member of polygonal orcircular cross-section. Also, it can be configured to directly engagethe connector 94 directly or other structure formed on the connector 94(See FIGS. 3G-I). In another aspect, the pusher can be sized to surroundthe first anchor member 82 and to engage a tail (See FIGS. 4G-I) forexample, of the anchor member once the pusher is pulled proximally withrespect to the anchor member. When the pusher 116 initially surroundsthe anchor member (or other structure formed directly on the connector94), the tail is held in compression, only to be released to extendlaterally from the connector when the pusher is moved proximally. Inthis way, the pusher assembly 116 can both be withdrawn when desired andadvance the anchor member 82 and connector structure 94 when necessary.In another approach, the tail can be held in compression by the internalsurface of the needle (not shown).

As shown in FIG. 5H, the complete withdrawal of the pusher 116 andneedle assembly 112 exposes the full length of connector anchoringstructure for use in ultimately manipulating anatomical structures. Suchcomplete withdrawal involves both the pusher 116 and needle assembly tobe housed completely within the needle housing 58.

Alternative approaches for advancing anchor components within the anchordelivery device 20 are contemplated. That is, rather than having apusher assembly which surrounds an anchoring component and relies uponengagement with a tail structure of an anchoring component or otherstructure projecting from the connector member, other structure can beemployed to provide the ability to push and pull an anchor component. Inone such approach (See FIGS. 6A-C), the delivery device can be equippedwith a pusher member 116 in combination with a pull wire 118. The pushermember 116 in this approach remains proximal an anchor member 82 to beadvanced along the delivery device. Such anchor members 82 can be placedin a position distal the pusher, for example, by being released from acartridge configured distal to the pusher position or the deliverydevice can be a single use apparatus.

The anchor member 82, in turn, can include a proximal portioncharacterized by a pair of elastically or plastically deformable arms120 which in a first configuration are held to the pull wire 118 and ina second configuration, are released from the pull wire 118.Accordingly, the pusher member 116 is advanced with respect to the pullwires 118 to cause the arms 120 to become disengaged from the pull wire.In the embodiment shown in FIGS. 6A and B, the arms 120 are plasticallydeformable whereas the arms 120 of the anchor member 82 of FIG. 6C areelastically deformable. The elastically deformable arms 120 can beformed from resilient material such as nitinol. The plasticallydeformable arms 120 on the other hand can be made from less resilientmaterial.

Further alternative embodiments of pusher members 116 are shown in FIGS.6D-G. A pusher member 118 having a D-shaped cross-sectional profile iscontemplated for certain uses. Such a profile enables the pusher member116 to be placed along side the anchor component 82 and connector 94assembly, a distal portion of the D-shaped configuration engagingcomplementary structure on the connector assembly.

Also contemplated is a pusher assembly 116 which includes a side opening122 in communication with a lumen extending through the pusher 116 (SeeFIG. 6E). Threaded through the side opening 122 is a distal portion ofthe anchor component 82 and connector 94 assembly. In this arrangement,the distal-most anchor component 82 is placed against the terminal endof the pusher member 116 to accomplish advancement of the anchorcomponent 82 and connector 116 assembly as the pusher 116 is extendeddistally.

In yet another approach, as shown in FIGS. 6F and G, the pusher member116 includes a terminal end 123 configured with a D-shaped profilesuited to engage and advance an anchor/connector assembly 94. A proximalsection of the pusher 116 is equipped with a plurality of spaced detentsor cavities 124 sized and shaped to receive anchor components 82 orother structure formed on the connector 94. In this approach also, thepusher member 116 is configured to reside longitudinally adjacent theanchor/connector assembly 82, 94. Advancement of the anchor/connectorassembly 82, 94 is accomplished through an engagement between certain ofthe anchor/connector assemblies 82, 94 and the cavities 124.

Various measures can be taken to ensure proper loading of a first anchormember 82 within an anchor delivery device. In a first step, the anchormember 82 is loaded within an anchor protection cover 126 (FIG. 7A). Apusher member 116 is configured proximal to the connector 94 of thefirst anchor member 82 to accomplish advancement of the first anchormember 82 into and through the needle assembly 112 (See FIGS. 7B and C).This subassembly is insertable within a delivery device bay 128. Adistal portion 130 of an interior of the delivery device bay is equippedwith a conical taper configured to receive a distal complementaryportion of the anchor protection cover 126 thereby accomplishing thecentering of anchor member within the delivery bay 128. An internallumen extends the length of the protection cover 126 and the cover 126includes a ring seal 132 placed within a proximal end thereof. The ringseal 132 functions to hold the cover 126 on a pusher member 116.

The delivery device bay 128 can further include a bayonet lock mount 134that couples a spring loaded cartridge 136 to the delivery device bay128. Housed within the cartridge is a compression spring 138 configuredabout the pusher member 116. The spring cartridge 138 can also include alock-out structure 140 which operates to limit the tension placed on theanchor member 82 and connector 94 until the needle 112 is withdrawnsufficiently from the interventional site to avoid damage from theneedle 112 inadvertently engaging the anchor/connector assembly 82,94.That is, the pusher 116 includes a proximal end configured with ananchor deployment tab 142 that engages the lock-out structure 140,prohibiting the compression spring 138 from applying tension to theanchor/connector assembly 82, 94 before the needle assembly 112 is clearof the interventional site.

In another contemplated variation (FIG. 7D), the anchor delivery devicecan be fashioned with a multi-shooter anchor cartridge assembly 144. Onefeature of this approach is the involvement of a manifold 146 includingfour entries which feed into a lumen extending into a needle assembly112, each entry configured to receive one anchor/connector assembly82,94. Proximal sections of the connector 94 are configured into spools148 which are driven by a torsional spring drive shaft 150. The driveshaft 150 is in turn, configured with complementary teeth structures 154formed on each spool. The assembly further includes structure (notshown) adapted to cause lateral movement in the driveshaft 150 so thatits teeth 152 indexes from spool to spool 148 to thereby turn the spools148 and advance the anchor members 82 within the needle assembly 112.Once the anchors 82 are advanced through the needle 112, the torsionspring retracts excess connector 94 length and clears the needle 112 forthe next anchor member 82.

It is further contemplated that in certain embodiments, the anchordelivery device can include the ability to detect forces being appliedthereby or other environmental conditions. Although various sections ofthe device can include such devices, in the depicted structure of FIG.7E, sensors 156 can be placed along the needle assembly 112. In thisway, an operator can detect for example, whether the needle has breachedthe target anatomical structure at the interventional site and theextent to which such breaching has occurred. Other sensors which candetect particular environmental features can also be employed such asblood or other chemical or constituent sensors. Moreover, one or morepressure sensors or sensors providing feedback on the state ofdeployment of the anchor assembly during delivery or after implantationare contemplated. For example, tension or depth feedback can bemonitored by these sensors. Further, such sensors can be incorporatedinto the anchor assembly itself, other structure of the deploymentdevice or in the anatomy.

In a next stage of anchor deployment, with reference to FIGS. 8A-E,after the first actuator 36 is completely released thereby effecting thecomplete withdrawal of both the needle assembly 112 and pusher member116, the second actuator 36 is pulled proximally to initiate theassembly of the second or proximal anchor member 52,98 (See FIG. 8A).Note that in FIGS. 8C, D and E, member 113 is shown in its advanced orforward position within slot 115, wherein member 119 is shown with itsterminal end truncated. With reference to FIG. 8B, which depictsinternal components of the integrated anchor assembly associated withthe second actuator (other structure being removed for betterunderstanding), as the second actuator 36 is depressed, it engages alever assembly 120 including a slotted portion 122 to drive a rackassembly 124 distally. The slotted portion 122 of the lever assembly 120provides the lever with the ability to both rotate with respect to amount 126 of the rack assembly 124 as well as advance the mount 126 aswell as the rest of the rack assembly 124 distally. Various pawls 130are provided to releasably lock the rack assembly 124 in desired stagesof advancement. It is to be recognized, however, that various otherapproaches to manually locking or unlocking structure for advancingcomponents of the second anchor assembly are contemplated. In thedepicted embodiment, the rack assembly 124, is in turn, connected to atelescoping pusher member which is configured to engage a second part othe second or proximal anchor assembly.

As shown in FIGS. 8C-E, depressing the second actuator 38 causes apusher 157 to advance a second part 98 of the second or proximal anchormember to be advanced towards and into locking engagement with the firstpart 52 of the second anchor member. As the second part 98 is advanced,it captures the connector structure 94 and retains it in a lockingengagement between the first 52 and second 98 parts.

It is at this stage that the connector 94 is severed to therebyaccomplish the formation of the complete anchoring assembly (See FIG.3E). In one embodiment, the severing can be effected by the advancementof the telescoping pusher member via the depression of the secondactuator 38. Alternatively, the severing action is operativelyassociated with the actuation of the third actuator 40. Thereafter, thesecond actuator 38 is released, automatically or manually, to permit there-staging of both the first 52 and second 98 parts of the secondanchoring member. That is, in one contemplated approach, members 113 and119 are withdrawn to allow the release and deployment of the secondanchoring member 52, 98 and then advanced again after the desiredstaging of component 52.

The present invention also contemplates a myriad of alternativeembodiments of the proximal or second anchoring member. In a majority inthe next presented descriptions regarding these embodiments, the secondanchoring member is comprised of a first part 52 which is placed into alocking engagement with a second part 98. In doing so, the first 52 andsecond parts 98 are affixed to the connector 94. It is to be recognizedthat the first and second parts can be formed of any conventionalmaterials such as metals or polymeric materials.

With reference to FIGS. 9A-C, the second anchoring member includes agenerally tubular first part 52 including a slightly flared mouthconfigured to receive both a portion of the connector 94 and a secondpart 98. In this embodiment, the second part includes a pair of spacedarms 158 which capture the connector and facilitates advancing theconnector within the mouth of the first part. It is contemplated thatthe arms 158 are spaced to an extent greater than an interior of thetubular first part 52 so that in combination with the area occupied bythe connector 94, a locking engagement between the first and secondparts is accomplished upon the full insertion of the second part 98within the first part 52. Thereafter, excess connector 94 length can becut away to form a complete second anchoring assembly.

In a slightly modified approach (FIGS. 9D-9F), the second part 98includes a spike-like terminal end portion 160 which can be configuredto engage the connector 94 and insert it within an interior of a tubularfirst part 52. The spike-like terminal end portion 160 defines a taperedstructure, a section with an enlarging dimension of which is sized andshaped to lockingly engage with the interior of the first part 52. Thecompleted assembly is characterized by a portion of the connector 94retained between the first 52 and second parts 98.

The approach depicted in FIGS. 9G and H is slightly different. Theconnector 94 is arranged to be threaded through a pair of oppositelyarranged apertures 162 formed in a generally tubular first part 52. Thefirst part 52 further includes a mouth equipped with a plurality ofproximally oriented, radially spaced arms 164. The second part 98 alsodefines a generally tubular structure, one having a section with asmaller outer profile than an interior of the first part 52. The secondpart 98 further includes a pair of distally oriented projections 166 aswell as a back end equipped with a gear-like collar 168. To accomplish alocking arrangement between the first 52 and second 98 parts, the secondpart 98 is inserted within the first part 52 so that the projections 166are configured on opposite sides of the connector. The collar 168 isthen used to rotate the second part 98 with respect to the first partuntil the connector 94 defines an S-shaped portion within an interior ofthe first part. The second part 98 is thereafter fully inserted into thefirst part, the gear-like collar being configured to register betweenthe radially spaced arms 164 of the first part 52 to thereby lock thetwo parts to each other. Furthermore, it is to be recognized that thesestructures of the first 52 and second 98 parts can be reversed in thatthe first part 52 can assume the structure of the described second partand vice versa.

The embodiments depicted in FIGS. 9I and J take a similar approach tothat shown in FIGS. 9G and H. That is, each take advantage of a lockingengagement resulting from the rotation of one part of the secondanchoring member with respect to the other. Again, each of theseembodiments include a first part 52 with pair of apertures 162 throughwhich a connector 94 is threaded. The assembly depicted in FIG. 9Iincludes a first part 52 configured with internal threads 168 which arecomplementary to external threads 170 formed on a second part 98. Thus,as the second part 98 is placed within the first part 52, it is rotated,the complementary threaded portions forming the locking engagementbetween the two parts. The assembly of FIG. 9J takes advantage of asecond part 98 including arms 166 which are bent radially outwardly andthe bent portion being sized to facilitate a locking arrangement with aninterior of the first part 52. This particular approach is alsocharacterized by the first 52 and second 98 parts having roundedterminal ends which provide an atraumatic surface which can be desirablein certain situations. Again, the structures of the first and secondparts can be reversed if desired as can those of the followingapproaches.

As shown in FIG. 9K, another approach involves a first part 52 includinga pair of proximally oriented projections 172 which can be formed bysplitting longitudinally the mouth to the generally tubular first part52. The connector 94 is captured between the distally oriented spacedprojections 166 of the second part 98 and the proximally orientedprojections 172 of the first part 52 as the second part 98 is insertedwithin the first part 52.

In yet another approach (FIG. 9L), the second part 98 is pre-loaded witha lock ring 174, which is oriented about the second part 98 at aproximal end portion thereof. As the second part 98 is advanced over aconnector and into engagement with a first part, its spaced arms 166enter an interior of the first part. Once the second part 98 is seatedwithin the first part, the lock ring 174 is then advanced over thesecond part 98 to accomplish a locking arrangement.

The first part 52 can also define a generally tubular member having anoval cross-sectional profile. Such a structure is depicted in FIGS. 9Mand N. Further, one of the oppositely oriented apertures 162 formed inthe first part 52 can further include a slotted-portion 172 sized toreceive a portion of a connector after the first part 52 is placed in alocking arrangement with the second part 98. The first part 52 furtherincludes a pair of openings 178 configured on opposite lateral sides ofthe device. In these embodiments, the second part 98 defines arelatively flat member, the distally oriented arms 166 of which includeprojections 180 having a ramped portion. Although different structure isemployed, both embodiments of the second part 98 further include asecond pair of projections 182 formed at proximal end portions of therespective devices. As the second parts 98 of these approaches isadvanced within the first part 52, the first projections 180 act tocompress the arms together then are advanced past the lateral apertures178 of the first part 52 and are configured beyond a distal end (notshown) of the first part 52. Once the second part 98 is fully insertedin the first part 52, the second pair of projections 182 register withinthe lateral openings 178 formed in the first part 52, thus forming alocking engagement.

The first part 52 can also be formed form a member having a deformable,enlarged mid-section 184 (See FIGS. 9O and P). In one approach, theenlarged mid-section 184 can be formed by longitudinally cutting aportion of the first part 52 and separating the material forming thisportion to define the opening 162 which is as before, intended toreceive a portion of the connector. As the second part 98 in the form ofa generally tubular sleeve is advanced over the first part 52, themid-section 184 is compressed, such compression effecting a lockingengagement between the first and second parts.

The second part 98 (See FIGS. 9Q and R) can also include laterallyspaced tabs 180 which slide within an interior of a generally tubularfirst part 52. The spaced areas 166 capture a portion of the connector94. Once the second part 98 is fully inserted within the first part 52,the laterally spaced tabs lock in place outside a proximal end of thefirst part 52. In the process, the portion of the connector 94 capturedby the arms 166 is compressed and held in place between the first 52 andsecond parts 98.

Turning now to FIGS. 9S-U, further approaches to accomplishing a lockingarrangement between first 52 and second 98 parts are presented. Theembodiment of FIG. 9S is characterized by a first part having agenerally oval cross-sectional profile and including both the firstlateral apertures 178 as well as a pair of oppositely oriented, secondlateral apertures 186. The second part is a generally flat membercharacterized by a proximal end configured with a stop in the form of aT-bar 184. As the second part 98 is advanced within the first part 52(not shown), the tabs 180 formed on the second part first registerwithin the first lateral openings 178. Thereafter, the second part isfurther inserted within the first part 52 to capture the connector whichis threaded through the apertures 162 formed in the first part 52. Yetfurther advancement of the second part 98 configure the detents 180within the second lateral openings 186 of the first part 52. Theproximal stop 188 is at this time placed in apposition with a proximalend of the first part.

In a similar approach (See FIGS. 9T-U), the generally flat second part98 includes both the first 180 and second 182 tab structures. As thesecond part 98 is advanced within the first part 52, the first tabs 180initially register within lateral openings 178 of the first part 52,which can act as a staging for subsequent advancement and capture of aconnector. Upon such subsequent advancement, the first tabs 180 are heldwithin an interior of the first part 52 and the second tabs 182 registerwithin the lateral openings 178 of the first part 52.

As shown in FIGS. 9V and W, the first part 52 can also assume a pin-likestructure with spaced arms 190. The second part 98 can define agenerally tubular structure including distally oriented arms 166.Insertion of the first part 52 within the second part 98 causes thespaced arms 190 of the first part 52 to compress about a portion of aconnector to form a locking arrangement. It is to be recognized thatthis approach to a locking arrangement can be modified in principle, inthat, as stated above, the structures of the first 52 and second 98parts can be reversed.

Moreover, the second part 98 can assume a generally tubular structureincluding a cutting projection 192 (See FIG. 9X) arranged to engage aconnector 94 upon insertion of the first part 52 within the second part98. In this way, further action beyond placing the first 52 and second98 parts into locking engagement, is not required to sever the connector94. Again, it is to be recognized that the structures of the first 52and second 98 parts can be reversed to also take advantage of thisapproach.

In a number of related approaches (See FIGS. 9Y-9AH), the secondanchoring component can be formed of a single integral locking member194. Certain of these members 194 are intended to be formed ofplastically deformable material so that it can first assume a generallyopen configuration and then be deformed to define a closed position in alocking arrangement about a connector member. Alternatively, thesemembers 194 can be formed of resilient material and be first held openand then allowed to self-collapse about a connector. In one such lockingmember (FIGS. 9Y), the integral member 194 is generally V-shaped andincludes a pair of diverging arms 198 which can be arranged into lockingcontact with a connector 194. Another locking member 194 (FIG. 9Z) ischaracterized by a clam shell profile, an interior of the arms 196 ofwhich is suited to lock with a portion of a connector 94. The lockingmember 194 of FIG. 9AA is also generally V-shaped and further includes apair of diverging arms 196, one of which includes bosses 198 designed tomate with recesses 200. A center section of one arm 196 is bent toprovide space to receive a connector.

In FIGS. 9AB-AC, there is shown a plastically deformable locking member194 that is configured with a collapsible aperture 202. In an undeformedconfiguration, the aperture 202 is formed by walls defining a generallyhour glass shape. Applying a longitudinal compression force to thelocking member 194 causes the aperture 202 to collapse about and lockwith a portion of a connector 94, the walls deforming inwardly andengaging the connector 94.

The locking member 194 can also be embodied in a device including amid-section characterized by helically arranged members 204 (See FIGS.9AD-AE). The opening 202 defined by the helical member 204 is sized toreceive a connector member. This device can either be formed ofplastically or elastically deformable materials such that collapsing theopening 202 about a connector can be accomplished through theapplication of a force to the locking member 194 or by removing acompression force from the member.

In still yet other approaches (FIGS. 9AF-9AH), the locking member 194can be embodied in a member including diverging arms 196 projecting froma cylindrical base 204. One arm includes a boss or raised portion 198sized to fit within a recess 200. A mid-section of the device furtherincludes a generally circular space 206 defined by semi-circular cutoutsformed in the opposing arms 196. This space is sized to lockingly engagea connector when the arms 196 are in a closed configuration. The lockingmember 194 of FIGS. 9AG-AH also includes this circular space 206 definedby semi-circular cutouts formed in the diverging opposing arms 196 aswell as the locking projections 198. However, rather than thecylindrical base 204 of the embodiment of FIG. 9AF, the arms 196 and thelocking member 194 extend proximally beyond the circular space 206. Thisportion of the arms 196 also include a complementary projection 198 andrecess 200 arrangement.

In a related approach (See FIG. 9AI), the locking member 194 can bedeformed about a connector 94 employing an anvil 210. Such an anvilcustom designed for the various approaches can be employed to deform theprevious disclosed embodiments of other members. As the locking member194 is advanced within the anvil, angled surfaces within an interior ofthe anvil operate to close the arms 196 of the locking member 194.Narrowed portions 212 of the locking member facilitate such closing ofthe arms about a portion of the connector 94. Once the arms are insertedinto an interior cavity 214 of the anvil 210, a cutting blade 216 seversthe connector 94 to length as desired.

Turning now to FIGS. 9AJ-K, further embodiments of a second anchoringmember including a first part 52 and a second part 98 are presented.

In these approaches, the second part 98 includes arms 196 which arebiased to an open configuration. Using an anvil 210 housing a first part52 in the interior cavity 214, the second part 98 is caused to beinserted and held within the first part 52. In a first embodiment (FIG.9AJ), the arms 196 of the second part 98 are relatively long compared tothose of a second embodiment (FIG. 9AK). In both approaches, however, agenerally tubular first part 52 retains the arms 196 in a closedposition in locking engagement about the connector 94.

Returning to the concept of a second anchoring member defining a lockingmember 194 (See FIGS. 9AL-AM), in still yet another approach thecapturing of the connector can be accomplished using a clip-likestructure. A pair of arms 196 begin at a proximal end of the device in aspaced arrangement. As the arms extend distally, they cross at mid-point218 beyond which a distal portion of the arms are adjacently arranged inapposition. One or both arms 196 can include a recess providing a spaceto allow the arms 196 to cross at the mid-point 218. Applying a force tothe proximal, spaced portion of the arms 196 causes the distal portionof the arms 196 to open. When opened, the arms 196 can be configured toreceive a connector. A closing force between the distal portion of thearms 196 of the locking member 194 accomplish locking the structure on aconnector.

The first part 52 of the second anchoring member can also be configuredfrom a flat sheet of material into which a pattern is cut to formvarious slots and tabs (See FIGS. 9AN-AO). These first parts 52 can beformed of material which is capable of self-forming from the flatconfiguration into a generally tubular configuration when unconstrained.For example, material such as nitinol which has memory properties can beused to form such structure. A first contemplated flat pattern (See FIG.9AN) includes a central five sided aperture 222 on either side of whichare configured slots 224 cut in from lateral side edges of thestructure. In a second pattern (FIG. 9AO), the lateral slots 222 arereplaced with cutouts which define tabs 226.

Irrespective of the specific form of the anchoring assembly, a next stepin the context of prostate treatment involves positioning the proximalanchor assembly 52, for example, within a desired section of the urethra(UT) of the patient (See FIG. 10A). Prior to doing so, the patient canbe monitored to determine whether there has been any evidence ofimprovement through the placement of the anchor. One such symptom iswhether there has been any urination. After so checking, the proximalanchor assembly 52 can be implanted. The patient is the again checkedfor evidence of improvement (i.e., flow improvement, visual appearance,opening of the urethra, urination, etc.). Next, the connector 94 issevered and the integrated anchor delivery device is withdrawn (See FIG.10B) and ultimately removed from the patient's body.

Accordingly, the present invention contemplates both pushing directly onanchor portions of an anchoring assembly as well as pushing directlyupon the connector of the anchor assembly. Moreover, as presented above,the distal or first anchoring component is advanced and deployed througha needle assembly and at least one component of the proximal or secondanchoring component is advanced and deployed through a generally tubularpotion of the anchor deployment device. Further, both a single anchorassembly or multiple anchor assemblies can be delivered and deployed atan intervention site by the deployment device. Consequently, in thecontext of prostate treatment, the present invention accomplishes thecompression of both the urethra and prostate gland, the delivering of animplant at the interventional site, applying tension between ends of theimplant, and the invagination of the implant within natural tissue.Moreover, drug delivery is both contemplated and described as a furtherremedy in BPH in treatment.

An alternate embodiment of a distal portion of an anchor delivery deviceis shown in FIGS. 11A-C. FIG. 11A depicts the device in a stage ofoperation where the needle assembly 112 has been extended through theneedle housing 60 and configured to project laterally from a distal endportion 48 of the device and is in the process of being withdrawn overthe connector 94 and first anchor member 82 assembly. FIG. 11B shows theposition of the pusher assembly 116 once the needle assembly has beenfully retracted within the needle housing 58. A retractable cover 228shown in its advanced position includes a side aperture 230 throughwhich the needle 112 and pusher 116 assemblies can be advanced tothereby place the connector 94 in a position for engagement by first andsecond 98 parts of the second anchoring member. To effect longitudinalmovement of the cover 228, a sliding arm 232 is provided and placed intoengagement with the cover. The sliding arm 232, in turn, is operativelyassociated with an actuator (not shown) pivotably attached to a devicehandle. In a further step of use (See FIG. 11C), the connector 94 issevered and equipped at its proximal end with one embodiment of a secondanchoring member assembly.

In one particular approach (See FIGS. 12A-B), the delivery device can beequipped with an alignment tube 234 including inwardly directed tabs 236sized and shaped to be received into complementary recesses formed insecond parts 98 of a second or proximal anchoring assembly. Such tabs230 not only provide structure for advancing the second parts 98 but italso ensures proper rotational alignment of the second part 98 as theyare advanced to receive a portion of the connector and to lockinglyengage with a first part of the second anchoring assembly.

With reference to FIGS. 13A-C, an integrated anchor 240 including aplurality of anchors 82 attached to each other by a connector 94 canalso be used to manipulate anatomical structures. In this approach, aneedle assembly 112 is utilized in a sewing motion to place variousportions of the integrated anchor 240 on opposite sides of anatomicalstructures to accomplish the desired manipulation at an interventionalsite.

The integrated anchor 240 can also be cut from a pattern (FIG. 13F) toform a device which can assume a generally straight tubularconfiguration (FIG. 13D) for delivery to an interventional site. Once atthe site, the device can be permitted to deform a generally H-shape(FIG. 13E), a first portion 252 being placed in apposition with a firstanatomical structure and a second portion 254 configured against asecond anatomical structure. A mid-section of the device can include aspring-like structure 256 which is particularly suited for applying atension to the first 252 and second 254 portions.

It is to be recognized that various materials are contemplated formanufacturing the disclosed devices. Moreover, one or more componentssuch as distal anchor, proximal anchor, connector, of the one or moreanchoring devices disclosed herein may be designed to be completely orpartially biodegradable or biofragmentable.

Moreover, as stated, the devices and methods disclosed herein may beused to treat a variety of pathologies in a variety of tubular organs ororgans comprising a cavity or a wall. Examples of such organs include,but are not limited to urethra, bowel, stomach, esophagus, trachea,bronchii, bronchial passageways, veins (e.g. for treating varicose veinsor valvular insufficiency), arteries, lymphatic vessels, ureters,bladder, cardiac atria or ventricles, uterus, fallopian tubes, etc.

Finally, it is to be appreciated that the invention has been describedhereabove with reference to certain examples or embodiments of theinvention but that various additions, deletions, alterations andmodifications may be made to those examples and embodiments withoutdeparting from the intended spirit and scope of the invention. Forexample, any element or attribute of one embodiment or example may beincorporated into or used with another embodiment or example, unless todo so would render the embodiment or example unpatentable or unsuitablefor its intended use. Also, for example, where the steps of a method aredescribed or listed in a particular order, the order of such steps maybe changed unless to do so would render the method unpatentable orunsuitable for its intended use. All reasonable additions, deletions,modifications and alterations are to be considered equivalents of thedescribed examples and embodiments and are to be included within thescope of the following claims.

Thus, it will be apparent from the foregoing that, while particularforms of the invention have been illustrated and described, variousmodifications can be made without parting from the spirit and scope ofthe invention.

We claim:
 1. A system for treatment of tissue at an interventional site,comprising: a deployment device comprising an elongate member having alongitudinal axis; and at least one retaining assembly including a firstanchoring member, a second anchoring member, and a connector; whereinthe deployment device is configured to deliver the first anchoringmember to tissue in a direction transverse to the longitudinal axis ofthe elongate member and wherein the deployment device is configured tofixedly join the first anchoring member to the second anchoring membervia a pusher assembly configured to crimp the connector within thesecond anchoring member, thereby preventing axial movement of theconnector with respect to the second anchoring member.
 2. The system ofclaim 1 wherein the deployment device further comprises a needle.
 3. Thesystem of claim 2 wherein the first anchoring member is carried by theneedle.
 4. The system of claim 3 wherein the first anchoring member iscarried within the needle.
 5. The system of claim 2 wherein the needletravels in a direction transverse to the longitudinal axis of theelongate member to deliver the first anchoring member to tissue.
 6. Thesystem of claim 2 wherein the connector is carried by the needle.
 7. Thesystem of claim 1 wherein the deployment device is configured to deliverthe first anchoring member to tissue with the connector fixedly joinedto the first anchoring member.
 8. The system of claim 1 wherein thedeployment device is configured to fixedly join the second anchoringmember to the connector such that a length of connector joining thefirst anchoring member to the second anchoring member is variable. 9.The system of claim 8 wherein the length is selectable by a user of thesystem.
 10. The system of claim 1 wherein the deployment device furthercomprises a cutter assembly.
 11. The system of 10 wherein the cuttingassembly is configured to cut the connector.
 12. A system for retainingtissue adjacent to a body lumen, comprising: a retainer comprising afirst endpiece, a second endpiece, and a connector, the retainercharacterized by a delivery configuration and a retaining configurationwherein the retaining configuration comprises the connector beingcrimped within the second endpiece and thereby being prevented frommoving axially with respect to the second endpiece; and a deliverydevice configured to position and assemble the retainer into theretaining configuration, wherein the delivery device is configured topenetrate tissue in a direction transverse to the longitudinal axis ofthe body lumen, and the delivery device comprises a sizing mechanismconfigured to assemble the retainer to a custom size, wherein the sizingmechanism comprises a pusher mechanism configured to assemble theretainer.
 13. A system for treating prostate tissue adjacent a urethrallumen, comprising: a delivery device comprising a needle, wherein thedelivery device is configured to be positioned at an interventional sitewithin the urethral lumen and wherein the needle is configured topenetrate prostate tissue in a direction transverse to the urethrallumen; and a retainer comprising a first endpiece, a second endpiece,and a connector, wherein the retainer is configured to be carried intoprostate tissue by the needle; and an assembly mechanism configured toassemble the retainer by crimping at least one endpiece to the connectorthereby preventing axial movement of the connector with respect to theone endpiece.
 14. The system of claim 13 wherein the assembly mechanismis configured to fixedly attach the second endpiece to the connector.